A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV.

OBJECTIVES: To evaluate the safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 22F, 23F, 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in children with HIV. DESIGN: This phase 3 study (NCT03921424) randomized participants 6-17 years of age with HIV (CD4 + T-cell count ≥200 cells/µl, plasma HIV RNA <50 000 copies/ml) to receive V114 or 13-valent PCV (PCV13) in a double-blind manner on Day 1, followed by PPSV23 at Week 8. METHODS: Adverse events (AEs), pneumococcal serotype-specific immunoglobulin G (IgG), and opsonophagocytic activity (OPA) were evaluated 30 days after each vaccination. RESULTS: The proportion of participants experiencing at least one AE post-PCV was 78.8% in the V114 group ( n  = 203) and 69.6% in the PCV13 group ( n  = 204); respective proportions post-PPSV23 were 75.4% ( n  = 203) and 77.2% ( n  = 202). There were no vaccine-related serious AEs. IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) were generally comparable between V114 and PCV13 for shared serotypes at Day 30, and were higher for V114 compared with PCV13 for the additional V114 serotypes 22F and 33F. Approximately 30 days after PPSV23, IgG GMCs and OPA GMTs were generally comparable between the V114 and PCV13 groups for all 15 serotypes in V114. CONCLUSIONS: In children with HIV, a sequential administration of V114 followed 8 weeks later with PPSV23 is well tolerated and induces immune responses for all 15 pneumococcal serotypes included in V114.

Evaluation of the bioMérieux VIDAS HIV Duo Quick and Anti-HCV assays for dried blood spot based serosurveillance.

Serosurveillance is central to monitoring our progress towards HIV and HCV elimination targets proposed for 2030. However, serosurveillance systems are ineffective without reliable serological assays for the detection of HIV and HCV antibodies. Assays should also be compatible with dried blood spot (DBS) samples to facilitate biological sample collection. The VIDAS HIV Duo Quick and Anti-HCV assays are sold as reagents strips and processed by the automated VIDAS benchtop immunoanalyser. While both assays have shown excellent performance in serum and plasma, performance data in DBS samples is lacking. In our study, we evaluate the performance of the VIDAS HIV Duo Quick and Anti-HCV assays in DBS (n = 725) collected during a cross-sectional serosurvey (the Transitions study). The VIDAS HIV Duo quick had a sensitivity and specificity of 94.5% (95% CI 85.1%, 98.5%) and 95.7% (95% CI 93.9%, 97.0%) respectively. Likewise, the VIDAS Anti-HCV had a sensitivity and specificity of 95.6% (95% CI 91.6%, 97.8%) and 95.6% (95% CI 93.5%, 97.0%) respectively. These assays are unlikely to be helpful in low-prevalence settings due to sub-optimal performance, but their performance could likely be improved by optimizing DBS elution protocols which was, unfortunately, not possible during our study.